Teva Metoprolol Tartrate Tablets

METOPROLOL TARTRATE 50 mg AND 100 mg TABLETS

PACKAGE LEAFLET: INFORMATION FORTHE USER

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this Ieaflet. You may need to read it again.

• If you have any further questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1 What Metoprolol is and what it is used for

2 What you need to know before you take Metoprolol

3 How to take Metoprolol

4 Possible side effects

5 How to store Metoprolol

6 Contents of the pack and other information

 

1 What Metoprolol is and what it is used for

Metoprolol belongs to a group of drugs called beta-blockers, which affect the heart and circulation.

Metoprolol tablets are used to:

• Manage high blood pressure

• Manage angina pectoris (chest pain) and heartbeat irregularities, and may also be given after a heart attack

• Prevent recurrent migraines

• Treat hyperthyroidism (an overactive thyroid gland).

 

2 What you need to know before you take Metoprolol

Do NOT take Metoprolol if you

• Are allergic to metoprolol tartrate or any of the other ingredients of this medicine (listed in section 6)

• Are allergic to any other beta-blocker drugs

• Have severe asthma or severe attacks of wheezing

• Have heart failure, severe slow heart beat, irregular heart beat, narrowing of the arteries or had a heart attack with complications

• Have second or third degree heart block (a condition which may be treated by a
pacemaker)

• Have low blood pressure

• Have poor circulation

• You been told that you have high blood pressure due to a tumour near your kidney (phaeochromocytoma)

• Are pregnant or breast-feeding

• Have metabolic acidosis (a condition where there is a change in the acid/base balance of the body).

 

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Metoprolol. If you:

• Have a history of or suffer from allergies

• Have any other heart problems, in particular, a slow heartbeat

• Have poor blood circulation or controlled heart failure

• Suffer from psoriasis (patches of thickened and sore skin)

• Are diabetic. Your treatment for diabetes may need to be adjusted

• Have any liver problems

• Have a history of asthma or wheezing or any similar lung disorder

• Have recently suffered a severe allergic reaction

• Have a tumour of the adrenal gland (phaeochromocytoma)

• Have a type of chest pain (angina) called prinzmetal’s angina

• Have first degree heart block

• Have thyrotoxicosis (a condition caused by an overactive thyroid gland).Your medicine may hide the symptoms of thyrotoxicosis.

• Suffer from eye disorders.

If you are about to undergo surgery requiring anaesthetic, tell your doctor or dentist that you are taking Metoprolol.

 

Other medicines and Metoprolol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines of the following:

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and metoprolol together, do not stop taking clonidine unless your doctor has told you to do so. If you have to stop taking clonidine or metoprolol, your doctor will give you careful instructions about how to do it.

• Other drugs for your heart or to reduce blood pressure, e.g. prazosin

• Other beta blockers, e.g. timolol, for glaucoma

• Monoamine-oxidase inhibitors, for depression, e.g. phenelzine

• Verapamil, diltiazem, hydralazine, nifedipine (used to treat heart problems)

• Quinidine, amiodarone (for heart problems)

• Cimetidine (used to treat heartburn)

• Cardiac glycosides e.g. digoxin (used to treat heart failure)

• Rifampicin (used to treat tuberculosis)

• Lidocaine (used as a local anaesthetic to relieve pain)

• Ergotamine (used to treat migraine)

• Medicines to treat other mental illnesses (such as phenothiazines)

• Antiretroviral drugs (e.g. ritonavir) used to treat AIDS and some other conditions

• Drugs to prevent malaria

• Medicines to treat fungal infections

• Adrenaline (used in emergency treatment e.g. allergic reactions)

• Indometacin and celecoxib (used to treat inflammation of the joints, gout and period pain) medicines for the treatment of diabetes (including insulin).Your doctor may need to adjust your dose of these medicines.

Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines, including medicines obtained without a prescription.

 

Taking Metoprolol with food, drink and alcohol

You should keep your alcohol intake to a minimum while you are taking Metoprolol, as alcohol may increase the effect of this drug.

 

Pregnancy, breast-feeding and fertility

If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

Metoprolol may cause dizziness and tiredness, if affected do not drive or operate machinery.

 

Metoprolol contains Lactose monohydrate

Patients who are intolerant to lactose should note that Metoprolol Tablets contain a small amount of lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

 

3 How to take Metoprolol

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor, pharmacist or nurse if you are not sure. The tablets should be swallowed preferably with a glass of water. Metoprolol can be taken with or without food.

The recommended dose is:

Adults

High blood pressure

Initially 100 mg/day in the morning, which may be increased to a maximum of 400 mg daily.

Your doctor may combine this dose with a diuretic (water tablet) or another blood
pressure-lowering drug.

 

Angina

50 to 100 mg two or three times daily.

 

Irregular heartbeat

50 mg two or three times daily. If necessary this may be increased to 300 mg/day in divided doses.

 

Hyperthyroidism

50 mg four times daily. Your doctor may reduce the dosage as your condition improves.

 

Heart attack

The usual maintenance dose following a heart attack is 200 mg daily.

 

Migraine prevention

100 to 200 mg/day in divided doses.

 

Patients with liver problems

A reduced dose may be necessary.

 

Older people

A reduced dose may be necessary.

 

Use in children and adolescents

Metoprolol tablets are not recommended for use in children.

 

If you take more Metoprolol than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause low blood pressure (feeling dizzy or faint), a slow heartbeat, your heart may suddenly stop, difficulty breathing, reduced consciousness, feeling sick, being sick, blue discolouration of skin and coma. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

 

If you forget to take Metoprolol

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten tablet dose.

Take the remaining doses at the correct time.

 

If you stop taking Metoprolol

You should continue to take these tablets for as long as your doctor tells you to.

DO NOT stop taking your medicine without talking to your doctor first, even if you feel better. Your treatment with Metoprolol must not be stopped suddenly. If it is necessary to stop treatment, your doctor should reduce your dose gradually.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

 

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:

• An allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

 

The side effects listed below have been reported.

Common (may affect up to 1 in 10 people)

• Headache, dizziness, or unusual tiredness

• Slow heart beat

• Low blood pressure which might make you faint or dizzy

• Feeling short of breath when exercising

• Feeling or being sick, stomach ache

 

Rare (may affect up to 1 in 1,000 people)

• Depression

• Sleep disorders such as sleepiness, difficulty in sleeping or nightmares

• Feeling less alert

• Coldness, numbness or tingling in your hands and feet

• Muscle cramps

• Heart problems which can cause shortness of breath or ankle swelling (heart failure) or irregular heart beat or a very fast, uneven or forceful heartbeat

• Water retention (oedema)

• Poor blood circulation which makes the toes and fingers numb and pale (Raynaud’s phenomenon)

• Breathlessness or wheeziness (bronchospasm)

• Diarrhoea or constipation

• Skin rash (including nettle rash, patches of thickened and sore skin) and/or itching.

 

Very rare (may affect up to 1 in 10,000 people)

• Reduction in blood platelets, which increases risk of bleeding or bruising

• Weight gain

• Hallucinations or personality disorders

• Dry or sore eyes or problems with vision

• Ringing in the ears (tinnitus) or partial loss of hearing or deafness (hearing problems)

• Gangrene

• Runny and itchy nose (rhinitis), dry mouth

• Changes in the results of liver function tests

• Bruising or increased sensitivity of the skin to sunlight, worsening of patches of thickened and sore skin (psoriasis)

• Increased sweating, loss of hair (alopecia)

• Impotence or loss of libido

• Painful joints

• Chest pain.

 

Frequency not known (cannot be estimated from the available data)

• Confusion

• Abnormal levels of certain types of fats such as cholesterol or triglycerides in the blood

• Abnormal curvature of the penis with painful erections (known as Peyronie’s disease)

• Retroperitoneal fibrosis where abnormal scar tissue occurs behind the membrane that lines the cavity of the abdomen. This may present with pain in the back, groin or the lower abdomen

• Hepatitis

• Positive anti-nuclear antibodies (an indicator of autoimmune disease where the body attacks its own tissues)

• Memory loss, nervousness, anxiety, taste disturbance

• Conjunctivitis

• An increase in intermittent claudication (a cramp-like pain brought on by exercise).

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this Ieaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

 

5 How to store Metoprolol

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not use this medicine after the expiry date which is stated on the outer packaging. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

 

6 Contents of the pack and other information

What Metoprolol Tablets contain

• The active ingredient is metoprolol tartrate.

• The other ingredients are microcrystalline cellulose (E460), lactose monohydrate, sodium starch glycolate, colloidal anhydrous silica and magnesium stearate.

 

What Metoprolol Tablets look like and contents of the pack

• The 50 mg tablets are round, biconvex white tablets, engraved ‘4A5’ with a breakline on the reverse.

• The 100 mg tablets are round, biconvex white tablets, engraved ‘4A6’ with a breakline on the reverse.

• The product is available in pack sizes of 28, 30, 56, 60, 100, 500 tablets.

Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture:

TE VA UK Limited, Eastbourne, BN22 9AG

 

This leaflet was last revised: January 2015
PL 00289/0743-0744